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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000276-15 | Other Identifier | Federal Agency for medicine and health products |
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The purpose of this study is to determine if NIF fluorescent imaging is an effective approach to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer patients.
Primary objective:
Evaluation of the ability of NIR imaging to image and to detect the " viable " gross tumoral mass and/or peritoneal metastatic " implants " in women operated for ovarian carcinoma with peritoneal carcinomatosis after the IV injection of ICG ( which is approved for human use) the day before the operation.
Secondary objective:
Definition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (and, if any is demonstrated pre-operatively, in the nodes of these patients found fluorescent and removed).
however other goals of our project will be will be:
Hopefully ICG will be able to help, firstly, in the scoring of the peritoneal cancer index (PCI) enhancing the detection of small nodules which were undetected by normal visualization allowing a more 'complete' surgical treatment of the disease and secondarily, in the staging of these patients with the potential to upgrade patients from stage I/II to stage III in cases where fluoroscopy would allow to detect unknown minimal peritoneal carcinomatosis.
Methodology:
The day before the operation:
ICG 0.25 mg/kg will be given as an iv injection the day before the operation.
In the operating room:
When the patient will be opened, the surgeons will (under "conventional" video control) search ("in an orderly fashion") and establish "as usual" the presence of "gross" tumoral mass, of metastatic deposits and of "scars" at the level of the peritoneal surfaces. NIR imaging will be acquired during these maneuvers and fluorescent structures and/or foci will be anatomically defined by the surgeons.
The operation will be then continued as usual but each anatomical piece will be controlled "ex vivo" for its fluorescent character or not. All fluorescent foci on these anatomical pieces will be identified as such by a mark and/or by a "suture".
If lymph nodes were suspected to be metastatic (for instance on the basis of the PET-CT with 18F-DG performed before surgery), they will be searched, (optionally controlled in vivo for their visibility using NIR camera)and dissected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG NIR imaging | Other | see Summary and description iv injection of ICG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iv injection of ICG | Drug | An iv injection will be performed for the ovarian cancer patient before the operation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma | Evaluation of the feasibility of NIF imaging to detect tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma, the efficacy of this approach will be confirmed by histological test of the dissected tissue. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Veys, MD | Surgeon in Jules Bordet Institute | Principal Investigator |
| Gabriel Liberale, MD | Surgeon in Jules Bordet Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Bordet Institute | Brussels | B-1000 | Belgium |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D007725 | Krukenberg Tumor |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D018279 | Carcinoma, Signet Ring Cell |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |